This week we highlight a Food and Drug Administration approval for an alternative to LASIK, promising results for a less invasive brain interface device and a precision biotech who has recently raised an additional $100 million in funding. Finally, we look at additional FDA approvals for a wearable monitoring device and promising results in clinical trials for a potential opioid alternative. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest.
The FDA has granted STAAR Surgical Company approval for its EVO/EVO+ Visian® Implantable Collamer® Lens. The lens requires implantation by a trained doctor but differs from the traditional LASIK procedure because there is no removal of the corneal tissue and can be removed by a doctor if desired. EVO has already been implanted in more than one million people outside the U.S. and the company estimates that nearly one third or roughly 100 million people could be eligible to receive the device in the U.S.
Synchron announced that the company’s Stentrode device used to help patients with severe paralysis has remained safe with no serious adverse events in the four patients implanted with the device. The device is implanted through a patient’s vein and reduces the need for invasive brain surgery. The device allows the brain to signal commands to a laptop. Through this, patients can regain the ability to perform daily tasks including text messaging and sending emails. In December, one of the study participants became the first person to send a tweet through thought.
Neuron23 announced that it had closed its Series C funding round and raised an additional $100 million. The company develops precision medicines to treat neurological diseases. The company will leverage the capital raised to build out its platform and begin clinical trials later this year focused on a drug that inhibits a specific gene associated with an increased risk of Parkinson’s disease.
The FDA has recently approved Biobeat’s wearable device to monitor respiratory rate and body temperature. The approval adds to the company’s existing approval for vital signs including cuffless blood pressure, blood oxygen saturation and pulse rate. The platform provides a customizable early warning score system to help patients better monitor their critical vital signs and proactively address concerns with their care provider.
Vertex Pharmaceuticals shared that its Phase 2 clinical trials have demonstrated the ability to significantly reduce acute pain in people recovering from surgeries. The company said more information is needed before seeking FDA approval, but early indications appear promising as a stronger alternative compared to traditional over-the-counter painkiller drugs, and a potential alternative to opioids.